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CTRI Number  CTRI/2025/03/082581 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   IMMEDIATE EFFECT OF COLD AND NEUTRAL STREAM OF WATER OVER CHEST ON LUNG FUNCTION AMONG HEALTHY VOLUNTEERS  
Scientific Title of Study   Immediate Effect Of Cold And Neutral Douche Over Thoracic Region On Pulmonary Function Among Healthy Volunteers: A Randomized Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakshitha K 
Designation  MD Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire 
Address  Department of Natural Therapeutics Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7996186995  
Fax    
Email  dr.rakshithaborkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rakshitha K 
Designation  MD Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire 
Address  Department of Natural Therapeutics Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  7996186995  
Fax    
Email  dr.rakshithaborkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetha Kumari V 
Designation  Dean and Proffesor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire 
Address  Department Of Nutrition And Dietetics Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka
574240
Dakshina Kannada
KARNATAKA
574240
India 
Phone  9449714767  
Fax    
Email  Gbsujire@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital, Shantivana, Dharmasthala, Belthangady, Dakshina Kannada, Karnataka, India-574240 
 
Primary Sponsor  
Name  Dr Rakshitha K 
Address  Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire D.K Karnataka 574240 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakshitha K  Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, shantivana  COE Department of Yoga and Therapeutics Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India - 574216 Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 
7996186995

dr.rakshithaborkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College Of Naturopathy and Yogic Sciences Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Human Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold douche to thoracic area  The treatment will be given in the treatment room using specially designed douche apparatus , which is attached with temperature and pressure controlling unit. The patient will be asked to stand 1.5m away from the aperture. The treatment will start from horizontal jet to shoulder and arms with high pressure approximately 40-50 PSI(pound per square inch) and with the cold temperature ranging from 15-22 degree celcius. Followed by broken jet to front and sides of the chest and ending with the horizontal jet to the back of the chest and vertebral prominences. The duration of the treatment is 10 seconds to each part that will be 1 minute in total. 
Comparator Agent  Neutral douche to thoracic area  The treatment will be given in the treatment room using specially designed douche apparatus, which is attached with temperature and pressure controlling unit. The patient will be asked to stand 1.5m away from the aperture. The treatment will start from horizontal jet to shoulder and arms with high pressure approximately 40-50 PSI and with temperature ranging from 34-36 degree Celsius. Followed by broken jet to front and sides of the chest and ending with the horizontal jet to the back of the chest and vertebral prominences. The duration of the treatment is 10 seconds to each part that will be 1 minute in total. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Age ranging from 18 to 30 years
Subjects Who Are Willing To Participate In The Study
Gender: Both Male And Female 
 
ExclusionCriteria 
Details  Weak And Debilitating Individuals
Any Systemic Illness
Subjects With Open Wounds
Subjects Who Are Intolerant To Cold 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Forced vital capacity (FVC)
Forced expiratory volume at 1 second (FEV1)
Forced expiratory flow (FEF25-75%)
Peak expiratory flow (PEF)  
Pre, Post 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   12/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Naturopathy is a unique kind of primary care that combines modern research and scientific advancements with age-old healing practices. Fasting therapy, food therapy, hydrotherapy, massage therapy, mud therapy, chromotherapy, and air therapy are examples of non-invasive treatments.

Respiratory illness is linked to Autonomic nervous system (ANS) imbalance. Two possible presentations of asthma include imbalances between the parasympathetic and sympathetic nervous systems (PNS and SNS), or hyperfunction of the PNS in the airways. Numerous naturopathic treatments can be used to balance the autonomic nerve system. The number of people with chronic respiratory diseases globally in 2017 was 544·9 million (95% uncertainty range), which was a 39·8% rise from 1990.Localized douches can be utilized to treat illnesses of the respiratory system. Early hydrotherapy textbooks discuss how a brief cold application can aid to enhance lung function. Currently only one evidence is published on neutral douche, and no evidence of the effects of cold douche is currently available. Therefore, understanding how cold douche affects thoracic rebound in pulmonary function will be aided by this research. This will help to enhance the efficacy of hydrotherapeutic techniques.

 
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